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Top Stories
The $2.1-billion acquisition strengthens Novartis' position in nuclear medicine and radioligand therapy for treating cancer.
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The companies will join forces to develop and commercialize an oncology drug to treat hematological cancers.
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Industry News
A report from GlobalData, a data and analytics company, reveals the predicted role of immuno-oncology drug development and personalized medicine in the pharmaceutical industry in 2019.
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The agency sent a warning letter to Roche's Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.
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Supplier News
Horizon Discovery Group and C4X Discovery Holdings have entered into an exclusive partnership aimed at validating targets and developing next-generation oncology drugs.
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The STERIS ProKlenz ONE alkaline cleaner has a label performance claim for biofilm removal in addition to the product's existing label as a disinfectant and virucide.
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Bio/Pharma News
The company's biosimiliar to Roche's Avastin (bevacizumab) received a positive opinion for marketing authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP)
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Teva Pharmaceuticals and Neos Therapeutics entered into a settlement and licensing agreement to resolve all ongoing litigation involving Neos' patents protecting its Cotempla (methylphenidate) extended-release orally disintegrating tablets.
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Regulatory News
Sanofi has been granted marketing authorization by the European Commission for its dengue vaccine, Dengvaxia, following the earlier recommendation of approval by the EMA's CHMP.
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The agency has approved Stemline Therapeutics' Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm for both adults and pediatric patients.
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DRUG DELIVERY
Using training devices may ease patient anxiety about using autoinjectors and prefilled syringes, potentially leading to improved patient adherence.
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REGULATORY/GMP COMPLIANCE
FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products.
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MANUFACTURING
To improve production in pharmaceutical manufacturing, the IT, OT, and Quality functional groups must work together to get the most value from existing plant data.
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February 6–7, 2019
March 3–6, 2019
March 11–13, 2019
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eBOOKS
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The editors explore new tools for bio/pharma lab studies–such as robotics, augmented reality, and advanced instrumentation–as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing. |
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